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The product is intended to be used for diluting PureSperm® (K980814 and K984172) sperm separation medium to prepare the different layers of a density gradient. PureSperm® Buffer has been formulated to optimize the function of the original PureSperm®.

PureSperm® Buffer is supplied as a sterile (autoclaved SAL 10-3) isotonic salt solution. It is optimised for the dilution of PureSperm® or PureSperm® 100 in the preparation of density centrifugation gradients for separating and purifying human sperm. Two layers are commonly used for the gradient: 40% and 80%. This system effectively isolates the best sperm from lymphocytes, epithelial cells, abnormal or immature sperm, cell debris and bacteria. PureSperm® Buffer is CE marked in countries of the European Union. It is supplied in 100 and 250 ml bottles.

This document is a 510(k) summary for the PureSperm® Buffer, a medical device used in assisted reproduction. The information provided heavily emphasizes the substantial equivalence of the device to a predicate device rather than detailing specific performance criteria or a comprehensive study report in the way a contemporary AI/ML device submission would.

Therefore, many of the requested points regarding acceptance criteria, performance metrics, and study design are not applicable or not provided in this 2001 510(k) submission. This is typical for device submissions from this era, especially for reproductive media which are generally considered lower risk than software-as-a-medical-device.

Here is the information extracted and formatted to the best of what's available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The submission relies on "substantial equivalence" to a predicate device (K000621, SpermRinse™) rather than setting and meeting de novo acceptance criteria. Specific quantitative performance metrics are not specified in this summary.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "clinical trials and comparative testing," but no details are provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given the nature of the device (reproductive media) and the era of the submission, formal adjudication methods like 2+1 or 3+1 are highly unlikely to have been part of the assessment for this type of product.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size

• MRMC Study: No, an MRMC study was not done. This type of study is primarily relevant for imaging-based diagnostic devices where human readers are interpreting data, which is not the case for this reproductive media.
• Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was done

• Standalone Study: Not applicable. This device is a biochemical solution, not an algorithm or AI.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated. The submission primarily relies on "comparative testing" against a predicate device and "clinical trials." For reproductive media, ground truth would likely be established through in-vitro biological assays (e.g., sperm viability, motility, morphology post-processing) and potentially in-vivo outcomes data (e.g., fertilization rates, pregnancy rates in clinical use), but these details are not present in this 510(k) summary.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This device is a biochemical solution, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

• Ground Truth Establishment: Not applicable. This device is a biochemical solution, not an AI/ML algorithm.

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The product is intended to be used for the separation and purification of spermatozoa by density gradient centrifugation of human semen samples, where the prepared sperm are used for the treatment of involuntary infertility by utilizing one of the Assisted Reproductive Technologies (ART).

The product PureSperm® is a based on a buffered salt solution which contains a colloidal suspension of silica particles, with hydrophilic silane covalently bound to the particles. The pH, osmolality and salts of PureSperm® are formulated to be compatible with human sperm during their centrifugal separation and purification. The product is packaged in three bottle sizes, 100, 250 and 1000 mL, and these bottles, being Type I borosilicate glass, are packaged individually in white virgin-fibre cartons. Both the bottles and the cartons have pharmaceutically approved labels showing batch number, production date and expiration date. In addition, every carton contains an insert with a full description of the product, including instructions for use and precautions.

The provided text does not contain any information about acceptance criteria, detailed study designs, or performance metrics in the way a modern AI/software device submission would. This document is a 510(k) summary for a sperm separation medium (PureSperm®), a laboratory reagent, from 1998.

Here's why the requested information cannot be extracted and what can be inferred:

• Device Type: This is a chemical reagent, not a digital health/AI device. Therefore, the concepts of "algorithm performance," "ground truth," "training set," "test set," "multi-reader multi-case (MRMC) studies," or "human-in-the-loop performance" are not applicable in the context of this submission.
• Regulatory Era: This submission dates back to 1998, long before the current rigorous standards for clinical validation of AI/software as a medical device (SaMD) were established.
• Submission Content: The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on identical composition, product testing results, and intended use. It does not elaborate on detailed clinical trials or performance studies as would be expected for a diagnostic or therapeutic device today.

Therefore, I cannot fulfill your request for the specific numbered points (1-9) as they relate to AI/software device validation. The information is simply not present in the provided text.

What can be extracted and inferred from the text regarding its safety and effectiveness:

• Claim of Safety and Effectiveness: "The results of clinical trials and comparative testing against predicate products indicates that the new device is as safe and effective as the predicate devices." (Section 5)
• Basis for Equivalence: "Based on the identical composition, product testing results, and intended use, PureSperm® is substantially equivalent to the predicate device named above." (Section 6)
• Predicate Device: PureSperm® (K980814)

In summary, the document states that the device was deemed "safe and effective" and "substantially equivalent" to a predicate based on "clinical trials and comparative testing," but it does not provide any specifics about these trials, their methodology, acceptance criteria, or quantitative results.

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The product is intended to be used for the separation and purification of human sperm by density gradient centrifugation for intrauterine insemination (IUI).

The product PureSperm® is a based on a buffered salt solution which contains a colloidal suspension of silica particles, with hydrophilic silane covalently bound to the particles. The pH, osmolality and salts of PureSperm® are formulated to be compatible with human sperm during their centrifugal separation and purification. The product is packaged in three bottle sizes, 100, 250 and 1000 mL, and these bottles, being Type I borosilicate glass, are packaged individually in white virgin-fibre cartons. Both the bottles and the cartons have pharmaceutically approved labels showing batch number, production date and expiration date. In addition, every carton contains an insert with a full description of the product, including instructions for use and precautions.

The provided text is a 510(k) summary for the PureSperm® Sperm Separation Medium. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not include detailed information regarding specific acceptance criteria, a comprehensive study outline with performance metrics, sample sizes, ground truth establishment, or any details about AI integration.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

Specifically, the document states:

• "The results of clinical trials and comparative testing against predicate products indicates that the new device is as safe and effective as the predicate devices."
• "Based on the similarity of composition, product testing results, and intended use, PureSperm® is substantially equivalent to the predicate devices named above."

These statements are high-level conclusions and do not provide the detailed scientific study parameters that you have requested in your prompt. There is no table of acceptance criteria, no reported device performance metrics (e.g., sensitivity, specificity, accuracy, or any performance on sperm separation quality), no sample sizes for test or training sets, no information on experts, no adjudication methods, no mention of MRMC studies or AI involvement, and no specifics on how ground truth was established beyond a general mention of "product testing results."

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